Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
- Conditions
- Anal Fistula
- Interventions
- Procedure: treatment by radiofrequency
- Registration Number
- NCT03131297
- Lead Sponsor
- F Care Systems NV
- Brief Summary
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug...) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
* Fistula clinical healing 6 and 12 months after procedure
* Fistula MRI healing 12 months after procedure
* Anal continence before and after procedure
* Feasibility og radiofrequency procedure
* Morbidity
* Success and failure prognostics factors of this procedure
- Detailed Description
: Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug...) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
* Fistula clinical healing 6 and 12 months after procedure
* Fistula MRI healing 12 months after procedure
* Anal continence before and after procedure
* Feasibility og radiofrequency procedure
* Morbidity
* Success and failure prognostics factors of this procedure
Schedule :
* First inclusion march 2017
* Last inclusion march 2018
* Evaluations until march 2019.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Adult Patient agreeing to participate in the study and signing the consent to participate
- Patients with an anal fistula previously drained, without diverticulum> 10 mm in MRI after drainage.
- For women of childbearing age, they must have a negative urine pregnancy test
- Patient minor,
- Patients who are linguistically or psychologically unable to understand the information given and to give informed consent,
- Patient incapable, in the opinion of the investigator, to complete the self-questionnaires,
- Against-indication to radiofrequency treatment (infectious anal pathologies, anal fissures, residual staples of previous treatment Longo,
- Pregnant woman,
- Patient carrying a pacemaker,
- Patients participating in another clinical study,
- Against indication to the realization of an MRI,
- Patient with a fistula with insufficient drainage, against indicating the removal of the stem (congestive fistula, oozing, with internal and / or external congestive orifices).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anal fistula treated by radiofrequency treatment by radiofrequency treatment by radiofrequency: patient with anal fistula treated by radiofrequency
- Primary Outcome Measures
Name Time Method Clinical healing of an anal fistula 6 month Clinical healing of an anal fistula, 6 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow.
- Secondary Outcome Measures
Name Time Method evaluate anal continuation 12 months evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE
Determination of the optimal settings 12 months Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)
Assessment of Feasibility of anal fistula treatment by radiofrequency day 0 at inclusion Assessment of feasibility by measurement of anal fistula drying
Evolution in MRI 12 month If the MRI has eliminated an undrained pathway, a diverticulum greater than 10 mm, a hyper-intensity in T2 and after injection of Gadolinium.
Clinical healing of an anal fistula, 12 months Clinical healing of an anal fistula, 12 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow.
Prognostic factors 12 month Evaluate the prognostic factors of good or bad response to this treatment: type of fistula, settings of the probe and the drying of the fistula
Patient satisfaction 12 months self-assessment questionnaire with numerical scales
the rate and nature of post-operative complications 12 months Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment
Trial Locations
- Locations (4)
Clinique Blomet
🇫🇷Paris, France
Chu Nantes
🇫🇷Nantes, France
CHU Pontchaillou
🇫🇷Rennes, France
Hopital Bagatelle
🇫🇷Talence, France